This is a study planned to determine and compare immunogenicity and reactogenicity of MMR vaccine of SIIL delivered either with disposable-Syringe Jet Injector (DSJI) or disposable-syringe needle in total 340 Indian infants aged 15 to 18 months.
This is a randomized, observer blind, non-inferior, parallel group, multi-centre clinical study to determine and compare immunogenicity and reactogenicity of MMR vaccine of SIIL delivered either with disposable-Syringe Jet Injector (DSJI) or disposable-syringe needle in total 340 Indian infants aged 15 to 18 months. Sera samples will be analyzed by ELISA for seroconversion / seropositivity for each individual component of vaccine i.e. measles, mumps and rubella at 35 days after administration of a single dose of MMR vaccine of Serum Institute of India.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
341
Department of Paediatrics, Andhra Medical College, King George Hospital, Maharanipet,
Visakhapatnam, Andhra Pradesh, India
Krishna Institute of Medical Sciences Deemed University,
Karad, Maharashtra, India
Shirdi Sai Baba Rural Hospital, KEM Hospital Research Centre, Vadu Rural Health Program, Vadu Budruk, Tal: Shirur
Pune, Maharashtra, India
Seropositivity of individual child for measles, mumps and rubella
Seropositivity of the individual child for particular vaccine component will be defined according to the levels given in the kit literature.
Time frame: 35 days after administration of the study vaccines
Comparison of Geometric Mean titers (GMTs) for anti-measles, anti-mumps and anti-rubella antibodies
Time frame: Day 35
Solicited adverse reactions
Time frame: Day 14
Unsolicited adverse events
Time frame: Day 35
Serious adverse events (SAEs)
Time frame: Day 35
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Department of Pediatrics, KEM Hospital Research Centre, Sardar Moodliar Road, Rasta Peth,
Pune, Maharashtr, India
Department of Pediatrics, Bharati Vidyapeeth Deemed University Medical College and Hospital, Satara Road, Katraj, Dhankawadi
Pune, Maharasthra, India
Dept of Pediatrics, Sri Ramachandra Medical Centre, No. 1, Ramachandra nagar, Porur,
Chennai, Tamil Nadu, India